Thermo Fisher Scientific Launches LC-MS-Based Class I Medical Devices

HPLC, mass spectrometer and software designed for clinical analyses

Clinical laboratories now have access to a new high-performance liquid chromatography (HPLC), mass spectrometer (MS) and LC-MS software designed and manufactured as FDA Class I devices to be components of laboratory-developed tests for analyzing patient samples.

The Thermo Scientific Prelude MD HPLC utilizes TurboFlow technology to reduce manual sample clean-up steps and variability. The instrument features two parallel channels to enhance sample throughput, and the channels can run identical or different methods simultaneously.

The Thermo Scientific Endura MD Mass Spectrometer is designed to combine usability, excellent quantitative performance, sensitivity and robustness for high-confidence LC-MS results. The instrument is built to generate accurate, reliable quantitation over a wide range of sample sizes and concentrations.

Thermo Scientific ClinQuan MD software is written to streamline LC-MS workflows. It features three-tiered access to software functions with permission levels for technicians, supervisors, and directors as required by the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Audit trails simplify recordkeeping and protect the integrity of results.

These products made their debuts at the 2014 Annual Meeting & Clinical Expo of the American Association for Clinical Chemistry, McCormick Place, Chicago. Please click on the ‘request information’ tab below or follow the company website link for more information.

“We’re strongly committed to bringing the advantages of LC-MS to the clinical market, and these three products are the first of a larger initiative to make mass spectrometry more useful and accessible to the clinician,” said Dan Shine, president of chromatography and mass spectrometry for Thermo Fisher Scientific.